BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M

    MDR report key: 19380041 · Received May 23, 2024

    Report

    Report Number
    3005180920-2024-00319
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    April 25, 2024
    Report Date
    May 23, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 APRIL 2024: LOT 2347169: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-DEC-2023. EXPIRATION DATE: 2028-12-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 29 APRIL 2024. LINER: MPACT 01.32.3644HC10A FACE-CHANGING 10° PE HC LINER Ø36/E (K183582) LOT. 231940: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2023. EXPIRATION DATE: 2028-09-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610286 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M HIP BALL HEAD LZO MEDACTA INTERNATIONAL SA 2347169 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention